Computer Systems Validation Analyst II

Iovance Biotherapeutics

3d • $120,000 - $135,000

About The Position

The Computer Systems Validation Analyst II supports the full Computer Systems Validation (CSV) lifecycle, including documentation, implementation tasks, work prioritization, and escalation management. The role ensures compliance with regulatory requirements and delivers validation projects on time and within budget, working independently or collaboratively. The analyst generates lifecycle documentation that supports requirements such as 21 CFR Part 11, EU Annex 11, and data integrity standards. The scope includes direct-impact laboratory, manufacturing, and enterprise applications across multiple sites.

The position operates in a professional workplace or remote office environment and uses standard office equipment and keyboards. Remote employees are expected to maintain a safe workspace free of hazards. The role requires prolonged sitting or standing, occasional movement of objects weighing up to 10 pounds, visual work involving computer screens and extensive reading, repetitive wrist, hand, or finger motions, and communication with others. The stated annual base salary range is $120,000–$135,000, with individual pay decisions based on factors including location, role complexity, duties, and relevant education, experience, and skills.

Requirements

• Degree in Information Technology, Life Science, or a technical discipline.
• At least 5 years of relevant industry experience.
• Expertise with 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ data integrity principles.
• Experience with Agile, Waterfall, and hybrid SDLC models for regulated systems.
• Knowledge of computerized system lifecycle activities, CSV, and IT controls in a regulated environment.
• Demonstrated project management ability, strong written and verbal communication, and the ability to coordinate and navigate complex issues with internal and external parties.
• Detail-oriented and organized, with a focus on accurate, compliant documentation.
• Ability to work independently, manage multiple validation activities in a fast-paced environment, anticipate validation needs, and drive tasks to completion with minimal supervision.
• Ability to meet the physical and mental demands described, including prolonged sitting or standing, visual work, repetitive hand and wrist motions, communication, problem-solving, managing multiple priorities, handling work-related stress, and meeting deadlines.

Responsibilities

• Complete and document CSV lifecycle activities, including plans, risk assessments, user and functional requirements, specifications, data integrity assessments, testing, change controls, traceability matrices, qualification protocols, and validation and compliance reviews.
• Support validation of direct-impact laboratory, manufacturing, and enterprise applications across multiple sites.
• Ensure project deadlines and performance standards are met; respond to management, end-user, and client inquiries and provide frequent status updates.
• Collaborate with others to deliver validated computer systems to internal clients on time.
• Implement assigned change-control action items.
• Manage periodic reviews of computerized systems and data integrity and data quality.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform ad-hoc duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level